[Ip-health] Gilead Gets Subpoena From Justice Department

Tahir Amin tahir at i-mak.org
Sat Jun 18 09:50:22 PDT 2011

Note: the story on Gilead is from Pharmalot at:

On 18 June 2011 12:17, Tahir Amin <tahir at i-mak.org> wrote:

> The leading maker of drugs for AIDS and HIV has received a subpoena for
> documents related to its manufacture, quality and distribution practices
> from the US Attorney for the Northern District of California, according to a
> filing with the US Securities and Exchange Commission.
> The request applies to Atripla, Emtriva, Truvada and Viread - all of which
> are AIDS drugs - as well as the Hepsera hepatitis treatment; the Leitairis
> pulmonary hypertension med and an experimental fixed-dose combination of
> Truvada and Edurant. The drugmaker says it is cooperating in the civil and
> criminal investigation (see the SEC filing<http://www.sec.gov/Archives/edgar/data/882095/000129993311001765/exhibit1.htm>
> ).
> In a note to investors, ISI Group biotech analyst Mark Schoenebaum noted
> that Gilead has received similar subpoenas in the past - in December 2006,
> concerning marketing and medical education programs for Truvada, Viread and
> Emtriva; and in 2009, for sales and marketing of Ranexa. However, he pointed
> out that both investigations were resolved without any penalty.
> “…It will likely take years for full resolution (although Gilead says
> timing of resolution is unclear at this point), and the worst-case outcome
> is likely a fine (which could be substantial, depending on the outcome),” he
> writes. “We have no opinion, at this point, about the merits of the
> government’s case, so we can’t opine on the probability of a fine at this
> point.”
> *UPDATE on Sunday, June 12*: Schoenebaum circulated another note over the
> weekend to point out that, unlike the current investigation, the previous
> probes were “not criminal in nature or related to manufacturing.” Although
> he add that Gilead informed him the current probe is not related to its San
> Dimas, California, facility that was the recent focus of an FDA 483
> inspection report and is also involved in the fill/finish process in all of
> the drugs cited in the subpoena.
> “While the ‘manufacturing’ language in the press release does not
> necessarily indicate that Gilead will have manufacturing interruptions, we
> cannot completely rule out this option…For now the company has not been
> willing to quantify or qualify the extent to which their operations may (or
> may not) be interrupted. Friday’s press release mentions many of GILD’s
> products including its two largest, Atripla and Truvada which make up about
> 90 percent of its revenues, so this is concerning, but this may be largely
> overblown.”
> He anticipates that if a fine is paid it would total somewhere between $200
> million and $750 million.
> --
> Tahir Amin
> Co-Founder and Director of IP
> Initiative for Medicines, Access & Knowledge (I-MAK)
> Email: tahir at i-mak.org
> www.i-mak.org

Tahir Amin
Co-Founder and Director of IP
Initiative for Medicines, Access & Knowledge (I-MAK)
Email: tahir at i-mak.org

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